Clinical Research Developments

 Clinical Research Developments

The development of clinical research or clinical trials is in line with the development of medical science. Medical science as a natural science (natural Science) develops in two ways, namely through observation and experimentation. 

This method of observation is carried out by recording the properties and symptoms that occur naturally, and in this way, information is then obtained about the natural course of the disease and the factors that influence it. While the way experiment is done by setting certain conditions to the object, then observing the changes that occur in the object. In medical/health sciences, these two methods support and complement each other.

The method of observation in medical research is very old age, the same as the age of medical science itself. Although it has many disadvantages, this method is still used today. The weaknesses of the observational method in medical science include: that the factors involved in causing and changing the history or course of the disease are so complex that by observation alone may not be found at all what is actually a sequence of causes and effects in the history of the disease. 

To overcome these shortcomings, the experts agreed to advocate the use of experimental methods. By using this experimental method every good idea for overcoming health/medical problems must be tested first before the truth is accepted.

Developments in the field of Medicine, until the 18th century in general, are still empirical, based on subjective assumptions in some patients. These assumptions are then coupled with traditions, beliefs, and superstitions passed on to the next generation (hereditary). Then at about the beginning of the 19th century, Claude Bernhard expressed the need for experiments in the development of medical science.

From that moment on, the treatment began to be experimentally tested through experimental animals, before being carried out on humans. In subsequent developments, although these drugs have shown benefits in animal experiments, they turned out doubtful benefits in humans. 

Even some of these drugs cause terrible effects, although animal experiments have been declared safe. It is also realized that between animals and humans there are species differences, which will in itself bring about differences in response.

Given these facts, in the framework of the development of medical science, especially in the field of medicine, it was decided that experimental research should be carried out on humans. But the use of the word experiment is avoided because it creates the impression of torture against humans, and is unethical. Therefore, drug research conducted on humans is hereinafter called clinical research or clinical trial.

Until now, the term clinical trial includes two definitions, namely: a) clinical trial as a series of drug research activities in humans; b) clinical trial as a research method that is experimental. Because clinical research is targeted at humans and concerns ethical, legal, social, cultural, and so on, a separate law is needed. But in Indonesia, so far there is no law about it. Developed countries generally already have laws on clinical research. According to the law, clinical research must meet three criteria, namely:

  1. Clinical research activities include the administration of drugs by doctors or dentists to patients.
  2. There is evidence that the drug has a beneficial effect on patients. 
  3. Administration of the drug aims to determine how much and to how far a drug has beneficial or adverse effects.

Clinical research as a research method is prospective and comparative research.

Source

Notoatmodjo, S. (2010). Notoatmodjo s Health Research Methodology, editor. Jakarta: PT. Rineka Cipta.

Creswell, J.W., & Miller, D. (2000). Determining validity in qualita¬tive inquiry. Theory into Practice, 39(3), 124-130.

Bowling, A. (2014). Research methods in health: investigating health and health services. McGraw-hill Education (UK).

Creswell, J. W., & Creswell, J. D. (2017). Research design: Qualitative, quantitative, and mixed methods approach. Sage publications.

Creswell, J.W. & Piano Clark, V.L. (2007). Designing and Conducting Mixed Methods Research. Thousand Oaks, CA: Sage.

Green, J., & Thorogood, N. (2018). Qualitative methods for health research. sage.

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